Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) announced that its Phase 3 KEYNOTE-412 trial of KEYTRUDA® (pembrolizumab) combined with chemoradiation therapy for unresected locally advanced head and neck squamous cell carcinoma (HNSCC) failed to meet its primary endpoint of event-free survival (EFS). While the trial showed some improvement in EFS compared to placebo, it did not achieve statistical significance. Despite this setback, Merck remains committed to exploring KEYTRUDA regimens for HNSCC in earlier disease stages, with plans to present detailed results at a medical meeting.

Merck (NYSE: MRK) has entered a global agreement with Orion for the development and commercialization of the investigational drug ODM-208, designed to inhibit CYP11A1, crucial in steroid production. Merck will pay Orion USD 290 million upfront, expensed in Q3 2022. Orion will recognize about EUR 220 million as income upon signing. The deal allows for future milestone payments and royalties on sales if ODM-208 is approved, presenting a significant opportunity for both companies in tackling metastatic castration-resistant prostate cancer.

Merck (NYSE: MRK) has launched the Merck Digital Sciences Studio (MDSS) aimed at fostering innovation in drug discovery by supporting early-stage biomedical startups. The MDSS will provide investments, access to Azure Cloud computing, and collaboration opportunities with Merck scientists. Applications are now open for 12 spots in the first cohort, with a focus on artificial intelligence (AI) and machine learning (ML) technologies. The initiative will be located in Newark, NJ, and Cambridge, MA, collaborating with the New Jersey Innovation Institute and supported by notable venture funds.

Merck (NYSE: MRK) will conduct its second-quarter 2022 sales and earnings conference call on July 28 at 8:00 a.m. ET. Company executives will present an overview of Merck's performance for the quarter and its outlook, accessible via a live audio webcast. The call can be joined by dialing designated numbers for the USA and international participants. A replay will be available on Merck's website along with supplemental disclosures. For over 130 years, Merck has been a leader in biopharmaceuticals, advancing health solutions globally.

AstraZeneca and Merck announced a positive recommendation from the European Medicines Agency for LYNPARZA in treating high-risk early breast cancer with gBRCA mutations. This follows the Phase 3 OlympiA trial, showing LYNPARZA improved invasive disease-free survival by 42% and overall survival by 32% compared to placebo. With breast cancer affecting 2.3 million globally in 2020, this treatment could significantly impact outcomes for HER2-negative patients in Europe. The drug is already approved in the U.S., EU, and Japan for various BRCA-related cancers.

Merck has received European Commission approval for KEYTRUDA as the first anti-PD-1 immunotherapy for adjuvant treatment in patients aged 12 and older with stage IIB and IIC melanoma post-complete resection. This decision follows positive outcomes from the Phase 3 KEYNOTE-716 trial, where KEYTRUDA significantly reduced the risk of recurrence by 39% and distant metastasis by 36%. The treatment underscores Merck's commitment to advancing melanoma therapies, addressing a significant public health issue that claimed over 26,000 lives in Europe in 2020.

VAXNEUVANCE has been recommended by the CDC's ACIP as a vaccination option for infants and children, marking the first new pediatric pneumococcal conjugate vaccine in nearly a decade. This 15-valent vaccine can be used in place of the existing 13-valent vaccine for children under 19 years. The recommendation aims to combat serious diseases in children under 5, highlighting its relevance as serotypes 22F and 33F are increasingly responsible for invasive diseases. The final recommendation will be formalized in the CDC's MMWR.

The FDA has approved an expanded indication for VAXNEUVANCE, a 15-valent pneumococcal conjugate vaccine by Merck (NYSE: MRK), for use in children aged 6 weeks to 17 years. Clinical trials showed VAXNEUVANCE elicited non-inferior immune responses to PCV13 for shared serotypes and superior responses for serotype 3 and unique serotypes 22F and 33F. This marks the first approval of a pediatric pneumococcal conjugate vaccine in nearly a decade, addressing serious health risks from invasive pneumococcal disease, particularly in children under 5.

Merck (NYSE: MRK) and AstraZeneca announced promising results from the Phase 3 PROpel trial, published in NEJM Evidence, showcasing LYNPARZA combined with abiraterone plus prednisone significantly improved radiographic progression-free survival (rPFS) in metastatic castration-resistant prostate cancer (mCRPC) patients. The trial results indicated a 34% reduction in disease progression risk, with median rPFS at 24.8 months for the combination therapy, compared to 16.6 months for standard treatment. This data could lead to new first-line treatment options for mCRPC.